Gomco Circumcision Clamps with separate O-Ring Component: The device… — Class II medical device recall Z-0947-2017
Terminated recall by Aesculap Implant Systems LLC, reported 2017-01-11, distributed nationwide. Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
| Recall number | Z-0947-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2016-10-28 |
| Classified | 2017-01-05 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2018-01-30 |
| Distributed | Nationwide (US) |
| Quantity | 437 units |
Product
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
Reason for recall
Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0947-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.